MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; NEEDLE,HYPODERM,SAFETY, 25GX1

Catalog Number	SSN100255
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	02/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the safety came off an stuck the nurse.".
Additional Manufacturer Narrative
According to the facility, after the nurse administered a vaccine, "the safety feature popped off of the hub and the nurse was unaware resulting in her being stuck with the needle"; the staff member required a lab draw for hiv testing, no additional medical care was provided, and the staff member is reported to be doing well.Medline received 1 bx of safety hypodermic needles in new condition and randomly selected 50 samples for visual inspection and functional testing by attaching each sample to a luer-lock medline syringe and using both safety needle technics shown on the instructions for use insert.The visual inspection revealed no manufacturing defects preventing the samples to work properly, all needles were safely covered by the safety shield and none of them were exposed after the mechanism was activated, and medline experienced no malfunctions with excessive force applied while activating the safety shield.The complaint was not confirmed; the samples worked as intended.There were no reports of death, serious injury, medical intervention, or follow up care.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this is a reportable event.If additional information becomes available this report will be reopened and reevaluated.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.

• Brand Name: MEDLINE
• Common Device Name: NEEDLE,HYPODERM,SAFETY, 25GX1
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: nitish sandadi ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50897192
• Report Number: 1417592-2026-50820
• Device Sequence Number: 5828885
• Product Code: FMF
• UDI-Device Identifier: 30193489031984
• UDI-Public: 30193489031984
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K213054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: SSN100255
• Device Lot Number: 897210550001
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/07/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2023
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown